Company: i-Pharm Consulting
Location: Frankfurt am Main
Closing Date: 15 Dec 16
Salary (£): 30,000 - 40,000
Regulatory Affairs CMC Manager (m/w)Office-based in Frankfurt a.M. / full-time & unlimited contractMy client is an international biotechnology company focusing on innovative cancer treatments. As they are growing rapidly, they are looking for a committed and entrepreneurial person to join the manufacturing team from a regulatory perspective. As a member of the team, you will soon be a participant in the next crucial step. ...
Regulatory Affairs CMC Manager (m/w)
Office-based in Frankfurt a.M. / full-time & unlimited contract
My client is an international biotechnology company focusing on innovative cancer treatments. As they are growing rapidly, they are looking for a committed and entrepreneurial person to join the manufacturing team from a regulatory perspective. As a member of the team, you will soon be a participant in the next crucial step. It will be your responsibility to review the regulatory requirements for clinical trials of individualized cancer therapies and to ensure that they are complied with.
Tasks and Responsibilities:
- You will soon be taking on the task of coordinating across locations CMC aspects in the production, testing and release of ATMPs.
- In this connection you will be creating the CMC documentation for inclusion in approval dossiers for clinical test products.
- You will also be reviewing the GMP documentation for consistency with the CMC dossiers and compliance with the specifications in pharmacopeias and directives.
- In addition, you will be developing regulatory strategies for personalized immunotherapies in consultation with the appropriate authorities (including scientific advice).
- And you will be working in cooperation with internal departments and external partners to coordinate strategies and procedures and their implementation.
- Completed course of studies in the natural sciences with a doctorate in chemistry, pharmacy, biochemistry, biology or comparable discipline
- Ideally 1-2 years in regulatory affairs CMC for biotechnological products
- Experience in the production or quality control of RNA, preferably in a GMP environment
- Experience coordinating complex projects and an acute sense of responsibility
- Experience writing the documents required for approval of clinical trials
- A structured, solution-oriented and independent approach to work
- Valid work permit for Germany
i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in Europe and Germany. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMO’s). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance, drug safety and Bioinformatics.
If you would like to discuss this vacancy further, please call Recruitment Consultant Christian Rommerskirchen on +49 89 71 677 25 41 or email: email@example.com.
If this role is not suitable, Christian is also available to discuss other possible positions or answer any general questions regarding your career and the current market.
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